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Use of Capnography for the Follow-up of Cystic Fibrosis Children

NCT04814797 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2021-07-30

No results posted yet for this study

Summary

The respiratory system involvement in cystic fibrosis(CF) influences the prognosis and course of disease. Respiratory assessment is based on spirometry, but its main parameter, the maximal expiratory volume in the first second (FEV1), does not reflect the initial peripheral impairment of airways. Another pulmonary function test (PFT) validated for CF children follow-up is measurement of "gas trapping", reflecting ventilation inhomogeneity and incipient airways impairment. "Gas trapping" can be obtained by lung volume measurement (functional residual capacity, FRC) by plethysmography and helium dilution technique, but these tests are inconvenient for children due to their long length (\~30min). A complete PFT is routinely performed once a year. It also includes a measurement of Lung Clearance Index (LCI) reflecting ventilation inhomogeneity. Capnography is a non-invasive PFT technique, does not require subject's active cooperation, is of short duration and could replace the traditional PFT for CF children follow-up. The capnograph is integrated into the device measuring LCI and data can be retrieved and analyzed afterwards. Capnographic indices reflect ventilation inhomogeneity.

The hypothesis is that capnographic indices change in the presence/absence of "gas trapping" in CF children.

The main objective is to show that the capnographic index of efficacy (EFFi) is significantly different between CF children "with gas trapping" and CF children "without gas trapping". The secondary objectives are:

* to compare the other capnographic indices between CF children "with gas trapping" and CF children "without gas trapping": the slope of the ascending phase, α; the slope of the alveolar plateau, β; the angle Q between α and β; the positive peak of the first-order derivative, F'CO2, which reflects the ascending phase; the first negative peak of the 2nd order derivative, F "CO2, which reflects the curvature between the ascending phase and the alveolar plateau.
* to compare the results of the capnographic indices with the results of the FEV1 in identifying the presence / absence of "gas trapping";
* to compare the results of the capnographic indices with the results of the LCI in identifying the presence / absence of "gas trapping"

Conditions

Interventions

OTHER

Capnography data included in Lung Clearance Index measurement

Capnography data included in Lung Clearance Index measurement (a pulmonary function test included in routinely yearly follow-up of cystic fibrosis children) will be collected and analyzed

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2021-10-30
Completion
2021-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04814797 on ClinicalTrials.gov